Chewing Gum with Tomatidine

ABSTRACT

A chewing gum with a liquid-fill composition and a surrounding gum region, with one or both containing active ingredients, such as herbal, medicinal and/or mineral elements or combinations thereof, present in an amount of at least about 0.05 mg.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 14/283,459,filed on May 21, 2014 (now U.S. Pat. No. 9,387,168), which is acontinuation-in-part application of pending prior application Ser. No.14/220,224 filed on Mar. 20, 2014 (now U.S. Pat. No. 9,253,991), whichis a continuation-in-part of pending application Ser. No. 12/052,054filed on Mar. 20, 2008 (now U.S. Pat. No. 8,679,522), which is acontinuation of application Ser. No. 11/084,707 filed on Mar. 17, 2005(now U.S. Pat. No. 7,351,425), which is a continuation of priorapplication Ser. No. 10/646,503 filed on Aug. 21, 2003 (now U.S. Pat.No. 6,869,614), which is a continuation of application Ser. No.10/316,700 filed on Dec. 10, 2002 (now U.S. Pat. No. 6,652,839), whichis a continuation of application Ser. No. 09/664,630 filed on Sep. 19,2000 (now U.S. Pat. No. 6,491,540) and claims priority from U.S.Provisional Patent Application No. 60/154,972 filed on Sep. 20, 1999.The entire disclosure of the prior applications are considered to bepart of the disclosure of the accompanying application and are herebyincorporated by reference.

FIELD OF THE INVENTION

The present invention is directed to functional gums, suckers (e.g.,lollipops) and lozenges, and more particularly, to a gum and/or suckerand/or lozenge that has at least an exterior and an interior component,having distinct metabolic and functional characteristics that correspondwith the ingredients contained therein.

BACKGROUND OF THE INVENTION

Throughout the ages, human beings have attempted to attain and maintainparticular body morphologies, and in particular, have attempted tocontrol their weight so as to conform with then-fashionable mores.During the recent past, a preference for less massive morphologies hasbeen in vogue and a populous genetically ill-equipped to conform withsuch weight characteristics is bombarded with images of svelte figuresin both male and female forms.

The desire of individuals to lose weight and specifically, to lose fattytissue, has become nearly an obsession in the United States and manyother countries. Any simple and safe method toward achieving a slimfigure is in great demand. Methods for losing weight include hundreds ofadvised diets, machines and methods for exercise, various psychiatrictechniques involving alteration in mental attitudes, and a variety ofsurgical techniques. Liposuction has created an entirely new surgicalcosmetic industry, but carries a small but significant risk and oftenleaves the patient with an unsightly cosmetic result due to theinflammatory reaction surrounding where the fatty tissue has beenremoved by a technique which produces a severe tissue reaction.

Obesity is a serious public health hazard, second in importance only totobacco. Approximately ⅓ of Americans are seriously overweight accordingto life insurance data. In approximately 12 million Americans, obesitysignificantly contributes toward the cause and complications of seriousdisease. Such conditions include heart and lung disease, many types ofcancer, diabetes, high blood pressure, and peripheral arterial disease.This is in addition to how obesity becomes a cosmetic problem. Beingoverly fat limits both length of life and its quality.

A multi-billion dollar industry has developed in an effort to controlweight. The many varied and expensive techniques employed speak to therelative ineffectiveness of the many techniques that have been tried toget rid of excess fat.

Obesity has recently been recognized as a public health hazard ofepidemic proportions by the World Health Organization. One of threeAmericans between the ages of 20-74 are obese (Body Mass Index>30 Kg/m²body surface). This amounts to 58 million people. The number of obeseadults has increased dramatically. In 1980 25% of US adults were obese.The equivalent figure was 33% in 1990. In Europe the equivalent figureis about 40%.

Obesity significantly contributes to the dangers of other diseases inapproximately half of those who exceed the threshold description ofobesity. For example, 19% of the cost of management of heart disease canbe ascribed to obesity. Obesity is also recognized as a co-morbid factorfor obese patients suffering from degenerative arthritis, peripheralvascular disease, and many forms of pulmonary disease such as emphysema.The expenditure for products, goods, and services in the management ofobesity is estimated to be $ 33 billion per year. This is 3%-4% of totalhealth care expenditure per year and exceeds that expended for AIDS andcancer.

Obesity is such a prevalent, important and distressing problem that itsmany methods for suggested management are too well known to deserve morethan listing. They include diets that exclude fats and high caloricelements, food supplements, appetite suppressants, exercise machines andregimes, biofeedback and other psychotherapeutic techniques, and avariety of operative techniques. Operations include a number of methodsfor decreasing the capacity the stomach, gastric by-pass operations,methods to shorten the small intestinal absorption surface, excision ofthe unwanted fat (lipectomy) and techniques of liposuction. Liposuctionis performed approximately 51,000 times each year in the US. The maximumamount of fat that can safely be removed is approximately 2 Kg. Being anoperative technique for removing fat, in this case by suction, itinevitably excites an inflammatory response at the operative site, whichresults not only in post operative inflammation but in subsequent unevenand unsightly scarring beneath the skin where the fat has been removed.

Incorporated by reference in its entirety are the following U.S. patentsdirected generally to chewing gum compositions, methods and apparatusfor making chewing gum, and in particular, methods for enabling one ofskill in the art to produce soft-centered chewing gums as contemplatedby the present invention. The novelty of the present invention, however,should be understood as being distinguished from such prior artreferences and such incorporation by reference is only provided forenabling support of the numerous ways in which the particular novelproduct can be manufactured. The U.S. patents incorporated by referenceare as follows: U.S. Pat. Nos. 5,922,347; 5,916,606; 5,912,030;5,900,230; 5,885,630; 5,866,179; 5,858,423; 5,846,557; 5,834,002;5,827,526; 5,824,291; 5,736,175; 4,156,740; 5,498,429; 4,466,983;4,157,402; 5,569,477; 5,125,819; 5,248,508; 4,975,288; 4,792,453;4,980,178; 4,683,138; 5,087,460; 4,292,329; 4,642,235; 4,316,915;4,513,012; 4,250,196; 5,431,929; and 4,647,450.

Weight control systems and methods have improved over the years. Indeed,the ancient Romans believed that the vomitorium was penance for theiruncontrollable feasting and drinking during long celebrations for theirvarious deities. Modern methods of weight control including arduous andsometimes bizarre workout routines and machines are no less peculiar inmodern times. Moreover, with the advent of liposuction, stomachstapling, etc., there appears to be no bounds beyond which humans willgo to attain desired physical characteristics as such relate to theirweight. The effect of such weight norms has created a $60 billion a yearmarket for diet and weight control products. It is estimated that nearlyhalf of all American women, and a quarter of all men, are on a diet atany given time. As is well known, however, most diets, studies haveshown, do not work for nine out of ten people who, after sufferingthrough such diets, quickly regain their weight and often exceed theirprevious body mass. Such an unfortunate volley of feasting and dietingleads not only to physical harm due to increased rates of diabetes,arterial sclerosis, and other physical health problems, but also to anoften devastating decreased estimation of a person's self-worth.

There is thus a long felt but unsolved need for an effective,inexpensive and easy way in which to provide health consciousindividuals with diet products to assist in achieving desired weightloss.

SUMMARY OF THE INVENTION

In one embodiment, the present invention is directed to a method andproduct which provides functional components such as, herbal, medicinaland/or vitamin substances for various applications (e.g., weight controlsubstances) to an individual other than through the consumption ofpills, suppositories, diet beverages and/or tasteless and low caloricfoodstuffs. In one embodiment, the present invention is directed to aparticular gum product having at its center a composition different fromthe surrounding gum and having distinct functional and metaboliccharacteristics. For example, various metabolism increasing componentscan be provided in the interior of a gum in a liquid or semi-liquid formwhile the gum itself can be of a traditional gum composition and/or mayincorporate various other desirable metabolic increasing components tosupplement and/or coact with components contained in the liquid centerof the gum. Indeed, in one particular embodiment of the presentinvention, time release capsules may be provided suspended in a liquidmedium inside a gum enclosure.

The present discussion pertains principally to a diet controlgum/lozenge/lollipop, but the present invention is not so limited andincludes one or more combinations of ingredients as set forth, forexample, in Tables I and II below, which may be useful in numerous andvaried applications. For illustration purposes only, however, thefollowing discusses weight loss applications of the present invention.In one embodiment, chewing of the gum-based product releases theinterior liquid substance, thus providing a product and a methoddesirable by weight conscious individuals who do not wish to publiclyannounce or disclose their dietary desires. In a preferred embodiment,the substance contained within the gum (e.g. the interior liquidsubstance) would have as a principal characteristic the capability ofincreasing a user's caloric burn rate (e.g. by increasing a person'smetabolism, adjusting/regulating hormonal activity in an individual,providing fiber to increase a person's feelings of satiety).

In a particular embodiment of the present invention, a gum is utilizedhaving liquid interior components surrounded by the dense gum, forexample, the interior having a density less than 10% as dense as theexterior gum, more preferably at least about 15% less dense, and morepreferably, at least about 35% less dense than the surrounding gum. Theinterior liquid components can be herbal, organic, natural, chemicaland/or hormonal in nature, and may be selected dependent upon theirindividual and synergistic characteristics, with the objective being toincrease a person's metabolism in order to achieve a higher caloric burnrate and/or to decrease the desire for additional food (e.g. generate afeeling of satiety or fullness). It is within the scope of the presentinvention to incorporate various known diet control substances in eitherthe gum material itself and/or in the liquid interior materialencompassed by the gum material. In a preferred embodiment, however, thesurrounding gum material is comprised of traditional gum flavors andcompositions and the interior liquid and/or semi-liquid (e.g. gel)components of the present invention comprise diet regulating substances.

Yet another embodiment of the present invention relates to a hard candysubstance (e.g. primarily comprising a natural sugar and corn syrupbase) often referred to as a “sucker” or “lollipop.” The interior of thesucker or lollipop, however, contains a less rigid, soft and/or liquidor semi-liquid component. The enclosed material of the lollipop includesmetabolic enhancers for weight and caloric control.

In still another embodiment, a lozenge can be manufactured having adenser exterior and a less dense interior, where either the interior orexterior of the lozenge, or both, contain diet controlling substances.Preferably, diet controlling substances are positioned within theinterior of such lozenges so as to facilitate the enjoyment by anindividual of consuming the lozenge without the possible unpleasantand/or undesirable taste characteristics of various dietary componentswithin the center of the lozenge.

It will be understood that one purpose of certain embodiments of thepresent invention is to increase metabolic efficiency and to burncalories in an individual. Herbal additives may be incorporated intosuch products to aid in the body's ability to digest food and/or toblock absorption of fat molecules into the system. For example, chitosancompositions can be utilized either in the interior and/or exterior ofthe gum, lollipop and lozenge embodiments desired above and hereafter.In addition to chitosan, other fiber-like components, vitamins andminerals (e.g., especially calcium compositions to treat osteoporosis)can be incorporated into the present invention to provide desiredfeelings of satiety or fullness to an individual using such productsand/or to treat various vitamin and/or mineral deficiencies.

While the present invention is primarily directed to administering dietcontrol substances to individuals, it should be understood that othermedicinal and/or nutritional and/or biological components can beadministered to animals in general (companion pets, livestock, etc.) butpreferably humans. Indeed, the present inventor believes that theadministration of medicinal compounds to young children can be greatlyfacilitated by use of the present invention given that children are moreapt to take medicine in the form of a lollipop, lozenge or gum,particularly if the taste and flavor and textural characteristics ofsuch candy products are preserved and effective amounts of desiredcomponents are delivered to such individuals when consuming suchproducts.

Muscle atrophy, or wasting, is caused by aging and a variety ofillnesses and injuries, including cancer, heart failure, and orthopedicinjuries. It makes people weak and fatigued, impairs physical activityand quality of life, and predisposes people to falls and fractures. Thecondition affects more than 50 million Americans annually, including 30million people over age 60, and often forces people into nursing homesor rehabilitation facilities. Skeletal muscle atrophy is a common anddebilitating condition that lacks an effective therapy. Althoughskeletal muscle atrophy has broad clinical impact, current treatmentrecommendations (e.g. physical rehabilitation, nutritional optimization,and treatment of underlying disease) are often ineffective and/orunfeasible. Moreover, a pharmacologic therapy does not exist. Thus,skeletal muscle atrophy represents a very large unmet medical need.

A natural small molecule from tomato plants, tomatidine, is believed tocause cell growth, especially in skeletal muscle tissue. Properlyadministered, such as via the methods and systems set forth herein,tomatidine is an effective agent to treat muscle atrophy and to furtherincrease strength and exercise capacity. Tomatidine is an inhibitor ofmuscle atrophy and thus has a use as a therapeutic agent for skeletalmuscle atrophy. Tomatidine is a steroidal alkaloid and the aglycone ofa-tomatine, an abundant glycoalkaloid in tomato plants that mediatesplant defense against fungi, bacteria, viruses and predatory insects.When consumed by animals, a-tomatine is hydrolyzed by stomach acid andintestinal bacteria to tomatidine, which is absorbed by the gut.Tomatidine's effects on skeletal muscle are unknown. However, thefinding that the mRNA expression signature of tomatidine negativelycorrelated to signatures of muscle atrophy suggest that tomatidine hasan anti-atrophic (anabolic) effect in skeletal muscle.

In one embodiment, a person having from one, preferably two, and morepreferably three pieces of center-filled chewing gum in a 24 hour periodof time, such gum containing tomatidine, is able to achieve thestimulation of skeletal muscle anabolism, leading to muscle hypertrophy,increased strength and improved exercise capacity. In still otherembodiments, especially those including one or more of the agents as setforth in Tables I and II, and especially at least one metabolicenhancer, tomatidine provided in at least a 1 mg per piece of gum, isbelieved to result in two major effects on body composition, namely,increased skeletal muscle and decreased fat. Tomatidine is believed tolimit the progression of skeletal muscle atrophy during fasting andmuscle disuse, and enhances the recovery from disuse skeletal muscleatrophy. Tomatidine and/or a-tomatine are also important components invarious embodiments of the present invention directed to inclusion intoso-called functional foods and nutraceuticals designed to maintainmuscle mass and function in persons without muscle atrophy. In additionto having potential utility in its own right, tomatidine supports theconcept that systems-based methods can be used to discover smallmolecules that improve skeletal muscle mass, function and metabolism.Such compounds could potentially have several beneficial uses forpatients and society in general.

Studies have shown that tomatidine fed mice had larger muscles, buttheir overall body weight did not change due to a corresponding loss offat. Thus, another aspect of the present invention directed to treatingobesity, is further enhanced by providing certain amounts of tomatidineas an effective compound in the treatment of obesity. Tomatidine is anatural compound derived from tomatoes and is produced whenalpha-tomatine, which is found in green tomatoes, is digested in thegut. Tomatidine is significantly more potent than ursolic acid inbuilding muscle tissue and has a different mechanism of action. Oneapplication of the present invention is to provide a center-filledchewing gum lollipop or lozenge that contains tomatidine, as well asother select agents (set forth herein) in a manner that is effective topreserve muscle mass and function during the aging process. Preferably,the compositions included in the gum center-fill or in the gum basematerial contain tomatidine without any ursolic acid.

As set forth in Tables I and II below, certain embodiments of thepresent invention are directed to a center-filled gum, lozenge orlollipop that includes particular combinations of active ingredients,including calcium, vitamin E and a chemotherapeutic agent and/or Herbalcomponent, which in certain embodiments consists of tomatidine.Incorporated herein by this reference are the following US patentpublications, which further demonstrate that tomatidine falls into suchclassifications set forth in Tables I and II herein, i.e. US PatentPublication Nos. 20140030332 to Baron, et. al., and 20070123448 toKaplan et al.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 represents one embodiment of the invention depicting both agum-based outer shell and a liquid or syrup center, both consisting ofall or some ingredients listed in Table I or Table II.

FIG. 2 represents another embodiment of the present invention in alollipop form.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The following table contains a list of possible components that may beincorporated into the center of the gum, lollipop and lozenge aspects ofthe present invention:

TABLE I Dexatrim Diuretics Chitosan Antacids Oatmeal fiber AntibioticsVitamins Herbal components Mineral supplements Stimulants Medicinalcomponents Metabolic enhancers Lipid substances (HDLs) Chemotherapeuticagents

The following U.S. issued patents are also incorporated herein byreference: U.S. Pat. No. 5,474,989 by Hasimoto et al., U.S. Pat. No.5,747,475 by Norquist et al., U.S. Pat. No. 5,830,883 by Block et al.,U.S. Pat. No. 5,880,109 by Nakamura et al., U.S. Pat. No. 4,963,367 byEcanow, U.S. Pat. No. 4,738,850 by Thakur et al., U.S. Pat. No.5,846,952 by Vournakis et al., and U.S. Pat. No. 4,223,023 by Furda. Itwill therefore be appreciated by one of skill in the art that variouscompositions, formulations, masking agents (e.g., to Amask@ unpleasantflavors and/or textures and/or mouth feel characteristics of vitamins,medicinal compounds, minerals, etc.) and binders can be combined withthe present structure of the present invention to achieve variousdesired purposes. For example, controlled release formulations areencompassed by the present invention as are the preparation and use ofvarious different carrier vehicles useful for medicinally administeringcompositions to animals, time release formulations, compositions havingdesirable solubility and dissolution rates, and the incorporation intothe present invention of food additives such as vitamins, pharmaceuticalpreparations and other compounds, specifically those that reduce theabsorption of lipids such a chitosan.

Both the gum with liquid-type fillers and the sucker with a gum-basedcenter can be comprised of one or more of the following: xanthan, guar,locust bean gum, karaya, gum tragacanth, carrageenans, alginates, gumarabic, corn syrup, sugar, starches, gum bases. While multiple recipesexist, most candy substances can also be made from natural and herbalsubstitutes listed in Table II. The cavities that are extruded in boththe gum and the lollipop can be made with one or more cavities that canbe filled with multiple bio-enhancing and weight management substances,compiling all or some of the properties in Table II. The combination ofthem will achieve various results. Example: Guarana and malluang andchitosan will create energy and a feeling of Afullness@ for theconsumer; chromium picolinate (RE. 33, 988) and ginseng and ginger willallow the user to burn calories more efficiently).

TABLE II Siberian Ginseng Vitamin E Green Tea Zinc Casgara SagradaMahuang Apple Pectin Astragalus Dandelion Guarana Chickweek Bee PollenGymnema Sylvestre Chromium Picolinate Licorice Bluegreen AlgaeBladderwrack Royal Jelly Ginger Damiana Magnesium Lecithin SarsaparillaGotu Kola Golden Seal Nettles Chitosan

The amounts of all or some of these ingredients can vary, preferablybeing present in an amount between no less than about 0.05 mg. The sizeof the gum exterior can be made of a size less than 4.5 grams to morethan 18.4 grams with the cavity center being able to accommodate avolume between 0.5 mg to more than 5 grams. The lollipop can be a totalsize of less than 0.65 oz. with the cavity center being a volume of nomore than 0.42 oz. and no less than 4.5 grams, to a size larger than1.35 oz. with a cavity center being of at least 19 grams.

In one particular embodiment, the invention is directed to a beverage,so-called a Bloody Mary beverage, that includes the following: in a 12fluid once serving: up to but not exceeding 9.9% alcohol (by volume); nofat; up to 1200 mg of sodium; 3 grams of protein; Vitamin C, Vitamin A,calcium, potassium and iron. In a preferred embodiment the beverageincludes water, tomato concentrate, natural grain spirits, high fructosecorn syrup, aloe vera juice, sodium chloride, vinegar, citric acid,taurine, pectin, ascorbic acid, and citrus aurantium extract. In stillother embodiments, the beverage includes the following: freshhorseradish, tomato juice, Tabasco, Worcestershire sauce, celery salt,and one of amontillado; cream sherry, and pure cane sugar. In yetanother embodiment, the present invention includes a beverage consistingof: water; a tomato concentrate having a tomato soluble solids contentof about 24% to about 36% by weight, ethyl alcohol, Vitamin C, VitaminA, calcium, potassium, iron, water, high fructose corn syrup, aloe verajuice, sodium chloride, vinegar, citric acid, taurine, pectin, ascorbicacid, and citrus aurantium extract, horseradish, Worcestershire sauce,and celery salt. Certain other embodiments are directed to a Bloody Marybeverage that has the benefits of an energy drink, and include at leastthe following: tomato juice containing lycopene, Ginger, Honey, taurineand caffeine. By way of providing additional background, context, and tofurther satisfy the written description requirements of 35 U.S.C. §112,the following references are incorporated by reference in theirentireties: U.S. Patent Publication No. 20130115329 to Savant, et al.and U.S. Pat. No. 8,202,561 to Livaich. One of skill in the art willfurther appreciate that the beverage ingredients of the above can alsobe incorporated into the chewing gum and lollipop embodiments as furtherdescribed herein.

While various embodiments of the present invention have been describedin detail, it is apparent that further modifications and adaptations ofthe invention will occur to those skilled in the art. However, it is tobe expressly understood that such modifications and adaptations arewithin the spirit and scope of the present invention.

1. A chewing gum product consisting essentially of a first substanceconfigured so as to have at least one cavity capable of retaining aliquid or semi-liquid substance as a second substance, wherein at leastsaid second substance has an active ingredient consisting essentially ofa chemotherapeutic agent and at least one ingredient selected from thegroup consisting of calcium, zinc, chromium picolinate, magnesium, ametabolic enhancer and combinations thereof, said active ingredientpresent in an amount of at least about 30 mg.
 2. (canceled)
 3. A BloodyMary beverage, comprising, (a) in a 12 fluid once serving: up to but notexceeding 9.9% alcohol by volume; no fat; up to 1200 mg of sodium; up to3 grams of protein; (b) Vitamin C, Vitamin A, calcium, potassium andiron; and (c) water, tomato concentrate, natural grain spirits, highfructose corn syrup, aloe vera juice, sodium chloride, vinegar, citricacid, taurine, pectin, ascorbic acid, and citrus aurantium extract. 4.The Bloody Mary beverage as set forth in claim 1, further comprising,fresh horseradish, tomato juice, Tabasco, Worcestershire sauce, celerysalt, and one of amontillado; cream sherry, and pure cane sugar.
 5. ABloody Mary beverage, comprising, water; a tomato concentrate having atomato soluble solids content of about 24% to about 36% by weight, ethylalcohol, Vitamin C, Vitamin A, calcium, potassium, iron, water, highfructose corn syrup, aloe vera juice, sodium chloride, vinegar, citricacid, taurine, pectin, ascorbic acid, and citrus aurantium extract,horseradish, Worcestershire sauce, and celery salt.
 6. The Bloody Marybeverage as set forth in claim 3, further comprising tomato juicecontaining lycopene, Ginger, Honey, taurine and caffeine.